Director, Global CMC Regulatory

Responsibilities

• Develop and lead execution of effective global CMC regulatory strategies to support initial marketing approvals and lifecycle management of RevMed's product portfolio.
• Oversee the preparation and submission of high-quality CMC dossiers for global marketing authorization applications and post-approval supplements/variations.
• Manage/lead interactions with Health Authorities as needed.
• Assess the global regulatory implications of proposed CMC changes and provide proactive, risk-based guidance to optimize implementation and maintain compliance.
• Interpret and apply global CMC regulatory guidance (FDA, EMA, ICH, PMDA, NMPA, MHRA, etc.) to ensure compliant and efficient regulatory pathways.
• Anticipate regulatory risks and proactively develop mitigation strategies aligned with commercial timelines.
• Partner with Regulatory Affairs, technical SMEs, and CROs to ensure alignment of global submission strategies while addressing region-specific CMC requirements and serve as the CMC regulatory representative on global commercial teams to provide guidance that enables efficient global execution.
• Provide strategic leadership, mentorship, and technical guidance to junior team members to foster professional development and team performance.

Requirements

• Bachelor’s degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related scientific discipline.
• Minimum of 15 years of experience in pharmaceutical / biotech drug development, including at least 5 years of hands-on global CMC regulatory affairs experience.
• Deep expertise in CMC development for new chemical entities (NCEs) and small molecules, with proven ability to manage complex technical content.
• Extensive experience leading global CMC regulatory strategy and global marketing approval applications across the US, Canada, Europe, UK, APAC, and LATAM regions.
• Strong knowledge of US and international GMP regulations, current industry practices, with a demonstrated ability to interpret and apply requirements across the product lifecycle.
• Prior experience in oncology product commercialization is a plus.